CORE1 Fixture

GUDID 08800023100778

Cybermed Inc.

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• Primary Device ID: 08800023100778
• NIH Device Record Key: 4a7ade26-3a31-4096-b404-f60f138c57df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CORE1 Fixture
• Version Model Number: C1R4011S
• Company DUNS: 688248447
• Company Name: Cybermed Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr
• Phone: +827051187131
• Email: kshwan95@cybermed.co.kr

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800023100778 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210039

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-07
• Device Publish Date: 2022-02-25

On-Brand Devices [CORE1 Fixture]

• 08800023101171: C1R4513O
• 08800023101164: C1R4511O
• 08800023101157: C1R4510O
• 08800023101140: C1R4508O
• 08800023101133: C1R4507O
• 08800023101126: C1R4013O
• 08800023101119: C1R4011O
• 08800023101102: C1R4010O
• 08800023101096: C1R4008O
• 08800023101089: C1R4007O
• 08800023101072: C1M3513O
• 08800023101065: C1M3511O
• 08800023101058: C1M3510O
• 08800023101041: C1M3508O
• 08800023100938: C1R5013
• 08800023100921: C1R5011
• 08800023100914: C1R5010
• 08800023100907: C1R5008
• 08800023100891: C1R5007
• 08800023100884: C1R4513
• 08800023100877: C1R4511
• 08800023100860: C1R4510
• 08800023100853: C1R4508
• 08800023100846: C1R4507
• 08800023100839: C1R4013
• 08800023100822: C1R4011
• 08800023100815: C1R4010
• 08800023100808: C1R4008
• 08800023100792: C1R4007
• 08800023100785: C1R4013S
• 08800023100778: C1R4011S
• 08800023100761: C1R4010S
• 08800023100754: C1R4008S
• 08800023100747: C1R4007S
• 08800023100730: C1M3513
• 08800023100723: C1M3511
• 08800023100716: C1M3510
• 08800023100709: C1M3508
• 08800023100693: C1M3513S
• 08800023100686: C1M3511S
• 08800023100679: C1M3510S
• 08800023100662: C1M3508S
• 08800023100655: C1M3013
• 08800023100648: C1M3011
• 08800023100631: C1M3010
• 08800023100624: C1M3008